← Back to Search

HEPA Filter

HEPA Filters for Bronchiolitis (BREATHE Trial)

N/A
Waitlist Available
Research Sponsored by IDeA States Pediatric Clinical Trials Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
First-time hospitalization for bronchiolitis
Age <12 months at hospital admission
Must not have
Chronic airway or respiratory conditions requiring home oxygen, mechanical ventilation, or tracheostomy dependence; known immunodeficiency, hemodynamically significant cardiac conditions including those requiring medication or oxygen; cystic fibrosis; neuromuscular disease; eligible for palivizumab (per AAP guidelines87)
Use of stand-alone home HEPA filtration other than study-related HEPA units in the home
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Summary

This trial will compare HEPA and carbon filters to improve indoor air quality in hospitalized children <12 months with bronchiolitis.

Who is the study for?
This trial is for babies under 12 months old hospitalized with their first case of bronchiolitis. They must live in a home with electricity, internet or cellular service, and speak English or Spanish. Babies can't join if they have chronic respiratory conditions, are on certain medications, plan to move soon, live with smokers/vapers, or if another child in the home is already enrolled.
What is being tested?
The study tests whether using HEPA filtration units at home for 24 weeks can improve air quality and help children recover from bronchiolitis. Half of the participants will get real HEPA filters while the other half will get placebo filters without active filtering capabilities.
What are the potential side effects?
Since this trial involves using air filtration units rather than medication, there are no direct side effects expected from the intervention itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
This is my first hospital visit for bronchiolitis.
Select...
I was under 1 year old when admitted to the hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe lung, heart conditions, or immune deficiencies.
Select...
I use a HEPA air filter at home not provided by the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of caregiver-reported symptom-free days (SFDs)
Secondary study objectives
Average Particulate Matter (PM2.5) levels
Total quality of life (QOL) score

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Intervention Group (Active Filter)Active Control1 Intervention
The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the "high" (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.
Group II: Control Group (No Filter)Placebo Group1 Intervention
The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.

Find a Location

Who is running the clinical trial?

IDeA States Pediatric Clinical Trials NetworkLead Sponsor
6 Previous Clinical Trials
1,029 Total Patients Enrolled
1 Trials studying Bronchiolitis
University of Vermont Medical CenterOTHER
41 Previous Clinical Trials
25,597 Total Patients Enrolled
University of MontanaOTHER
25 Previous Clinical Trials
3,340 Total Patients Enrolled

Media Library

Bronchiolitis Clinical Trial 2023: Winix 5500-2 HEPA filtration units Highlights & Side Effects. Trial Name: NCT05615870 — N/A
Bronchiolitis Patient Testimony for trial: Trial Name: NCT05615870 — N/A
~80 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top